Solid Tumor
Conditions
Keywords
Nanoparticles, Positron-Emission Tomography, Docetaxel, Neoplasms, Quantification
Brief summary
A clinical phase I, open-label PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel.
Detailed description
After patient inclusion an fludeoxyglucose-18 (\[18F\]-FDG) PET scan will be performed to delineate viable tumour lesions. On day 1, patients will receive a low dose of \[89Zr\]-Df-CriPec® docetaxel (corresponding to approximately 0.1-1 mg docetaxel) followed by maximally 3 \[89Zr\] PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 h - 9 days after administration) to evaluate biodistribution and tumour uptake. Two weeks later, the patients will receive unlabelled CriPec® docetaxel up to the Recommended Phase II Dose (RP2D) given every 3 weeks (Q3W) that will be determined in the phase I NAPOLY trial (CT-CL01), immediately followed by a second low dose of \[89Zr\]-Df-CriPec® docetaxel and maximally 3 \[89Zr\]PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 hrs - 9 days after administration) to evaluate biodistribution and tumour uptake with therapeutic dosage.
Interventions
DRUGCripec Docetaxel
89 Zirconium Cripec Docetaxel PET
Sponsors
Cristal Therapeutics
Amsterdam UMC, location VUmc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I, open-label, single centre immune-PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, candidates must meet the following eligibility criteria: 1\. Age ≥ 18 years 2 A pathologically confirmed diagnosis of advanced, recurrent and progressive cancer that is refractory to standard therapy or for which no standard therapy exist and where treatment with a taxane is an appropriate treatment option 3. Measurable or evaluable disease according to RECIST criteria v.1.1 Patient must have at least one measurable lesion with a short axis diameter of ≥ 2 cm. 4\. Performance status (WHO scale/ ECOG) ≤ 1 (appendix 2) 5. Estimated life expectancy of at least 12 weeks 6. Toxicities incurred as a result of previous anti-cancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 2 (as defined by CTCAE version 4.0) 7. ANC ≥ 1.5 x10E9/L; platelets ≥ 100 x 10E9/L; Haemoglobin ≥ 6.0 mmol/L (≥ 9.6 g/dL) 8. Creatinine ≤ 1.5 x upper limit of normal (ULN); or creatinine clearance ≥ 60 mL/ min (Cockcroft-Gault) 9 Serum bilirubin ≤1.5 x ULN, alkaline phosphatase, ASAT and ALAT ≤ 2.5 x ULN, unless related to liver metastases, in which case ≤ 5x ULN is allowed 10 Written informed consent according to local guidelines
Exclusion criteria
Candidates will be excluded from study entry if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection (visual) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm) | 14 days | Visual detection (absent/present) of tumor uptake |
| Detection (quantitative) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm) | 14 days | Measured by SUVpeak values of visual positive lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry of [89Zr]-Df-CriPec® docetaxel | 14 days | Based on 89Zr PK activity concentration (Bq/ml) and biodistribution \[89Zr\]-Df-CriPec® docetaxel scans |
| Optimal time point for PET imaging after [89Zr]-Df-CriPec® docetaxel administration | 14 days | As assesed by a multidisciplinairy team |
| Linearity between [89Zr]-Df-CriPec® docetaxel and total docetaxel | 14 days | Assessment of 89Zr PK (Bq/ml) and total docetaxel (ng/ml) |
| Biodistribution of low dose dose [89Zr]-Df-CriPec® docetaxel before and after administration of therapeutic dose of CriPec® docetaxel (quantified with %ID [89Zr] CriPec® docetaxel) | 14 days | Measured by defining volumes of interest (VOI) of various organs on PET scan and calculating %ID/kg |
Countries
Netherlands
Outcome results
None listed